This research trial studies a risk-based classification system for patients with newly diagnosed acute lymphoblastic leukemia. Gathering health information about patients with acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best treatment.

Further Study Information

PRIMARY OBJECTIVES:

I. To provide a risk classification scheme for all patients with newly diagnosed acute lymphoblastic leukemia (ALL), which will be used to assign treatment on Children's Oncology Group (COG) frontline ALL treatment studies.

III. To provide a central reference guide for all required and research studies that will be conducted in local and reference laboratories for all newly diagnosed ALL patients.

IV. To provide a mechanism for optional banking of leukemia and germline specimens for current and future research.

OUTLINE:

Patients undergo blood sample collection and bone marrow biopsies at baseline and during and after induction therapy for immunophenotyping for ALL confirmation and classification, deoxyribonucleic acid (DNA) ploidy, genomic variation, and cytogenetic (BCR-ABL, trisomies 4+10, and molecular testing for translocations) analysis by flow cytometry and fluorescent in situ hybridization (FISH). Immunophenotype results obtained on this study are used to determine patient's assignment to specific clinical-trial treatments. Some samples (leukemic and germline) may be banked for current and/or future analyses.

Eligibility Criteria

Inclusion Criteria:

Patient has newly diagnosed acute leukemia:

> 25% blasts on a bone marrow (BM) aspirate or

If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM biopsy or

Adequate samples must be provided to the reference and/or COG-approved cytogenetics laboratories to allow completion of the studies needed for risk-stratification

If a BM aspirate is not performed, or adequate material cannot be obtained, peripheral blood (PB) can be substituted for BM if there are at least 1,000 circulating blasts/uL (i.e., a white blood cell [WBC] count of 10,000/uL with 10% blasts or a WBC count of 5,000/uL with 20% blasts)

If an adequate BM aspirate cannot be obtained and there are fewer than 1,000/uL PB blasts, the patient is not eligible for AALL08B1 or a frontline COG ALL clinical trial

Patient has suspected ALL:

Patients whose blast morphology is obviously myeloid, or whose blasts are myeloperoxidase positive, should not be enrolled on AALL08B1; however, patients with true biphenotypic or bilineage leukemia (i.e., patient presents with blasts with significant expression of multiple lymphoid and myeloid markers such that assignment to a single lineage is not possible) are eligible to enroll in AALL08B1 for cell banking

Samples must be sent to a COG-approved cytogenetics laboratory, and COG Reference Laboratory studies

All patients and/or their parents or legal guardians must sign a written informed consent

All institutional, Food and Drug Administration (FDA) and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

Patient must not have received prior cytotoxic therapy except for steroids or intrathecal chemotherapy

Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy

Trial Contact Information

Trial Lead Organizations/Sponsors

Children's Oncology Group

National Cancer Institute

Karen Rabin, MD

Principal Investigator

Trial Sites

U.S.A.

Alabama

Birmingham

Children's Hospital of Alabama at University of Alabama at Birmingham

Alyssa T Reddy

Ph: 205-934-0309

Mobile

University of South Alabama Mitchell Cancer Institute

Felicia L Wilson

Ph: 251-665-8000

Alaska

Anchorage

Providence Cancer Center

Brenda J Wittman

Ph: 907-261-3109

Arizona

Mesa

Cardon Children's Medical Center

Xiaxin Li

Ph: 602-747-9738

Phoenix

Phoenix Children's Hospital

Jessica Boklan

Ph: 602-546-0920

Tucson

Arizona Cancer Center at University of Arizona Health Sciences Center

Lisa M Kopp

Ph: 520-626-9008

Arkansas

Little Rock

Arkansas Children's Hospital at the University of Arkansas for Medical Sciences

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.